NCT05054374

A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer

A Phase 1b / 2a, Open-label Platform Study to Evaluate Mirdametinib as Monotherapy or in Combination With Other Anticancer Agents in Patients With Advanced Solid Cancers Harboring MAPK-activating Mutations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to find out whether mirdametinib is a safe treatment for people with advanced solid tumor cancer that has certain mutations. Researchers will look at whether mirdametinib on its own or in combination with the drug fulvestrant is a safe treatment that causes few or mild side effects in people with advanced solid tumor cancer.

Conditions

• Breast Cancer
• Breast Cancer Stage IV
• HER2-negative Breast Cancer
• Solid Carcinoma
• MEK1 Gene Mutation
• MEK2 Gene Mutation
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Mirdametinib	Dose Level -2INT: 2mg PO BID, 3 weeks on/1 week off Dose Level -2: 2mg PO BID given continuously Dose Level -1INT: 3mg PO BID, 3 weeks on/1 week off Dose Level -1: 3mg PO BID given continuously Dose Level 1: 4mg PO BID given continuously Dose Level 2: 6mg PO BID given continuously Dose Level 3: 8mg PO BID given continuously
DRUG	Fulvestrant	The starting dose of mirdametinib in combination with fulvestrant in each Dose Level will be as follows: * Dose Level 1: mirdametinib 4 mg BID PO + fulvestrant * (Only to be triggered pending DLTs on higher Dose Levels as described below) * Dose Level -2: mirdametinib 2 mg BID PO continuous + fulvestrant, and Dose Level -2INT: mirdametinib 2 mg BID PO on 3 weeks on, 1 week off + fulvestrant

Timeline

• Start date: 2021-09-14
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2021-09-23
• Last updated: 2025-05-23
• Results posted: 2024-07-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study